We have developed a method and a device entitled prostate mechanical imager (PMI) for the real-time imaging of prostate using a transrectal probe equipped with a pressure sensor array and position tracking sensor. PMI operation is based on measurement of the stress pattern on the rectal wall when the probe is pressed against the prostate. Temporal and spatial changes in the stress pattern provide information on the elastic structure of the gland and allow two-dimensional (2-D) and three-dimensional (3-D) reconstruction of prostate anatomy and assessment of prostate mechanical properties. The data acquired allow the calculation of prostate features such as size, shape, nodularity, consistency/hardness, and mobility. The PMI prototype has been validated in laboratory experiments on prostate phantoms and in a clinical study. The results obtained on model systems and in vivo images from patients prove that PMI has potential to become a diagnostic tool that could largely supplant DRE through its higher sensitivity, quantitative record storage, ease-of-use and inherent low cost.
Objectives-To evaluate the ability of Prostate Mechanical Imaging (PMI) technology to provide an objective and reproducible image and to assess the prostate nodularity.Methods-The PMI device developed by Artann Laboratories was evaluated in a pilot clinical study. For the 168 patients (ages 44 to 94) presented to an urologist for prostate evaluation, PMIproduced images and assessment of prostate size, shape, consistency/hardness, mobility, nodularity, and was compared with digital rectal examination (DRE) findings. The PMI and DRE results were further tested for correlation against a transrectal ultrasound of the prostate (TRUS) guided biopsy for a sub-group of 21 patients with an elevated PSA level.Results-In 84% of the cases the PMI device was able to reconstruct 3-D and 2-D cross-sectional images of the prostate. The PMI System and DRE pre-tests were able to determine malignant nodules in 10 and 6 patients, respectively, of the 13 patients with biopsy-confirmed malignant inclusions. The PMI System findings were consistent with all 8 biopsy negative cases, while the DRE had 1 abnormal reading for this group. The correlation between PMI and DRE detection of palpable nodularity was 81%, as indicated by the area under the receiver operating characteristic (ROC) curve. Estimates of the prostate size provided by PMI and DRE were found to be statistically significantly correlated.Conclusions-The PMI has the potential to enable a physician to obtain, examine and store a three dimensional image of the prostate based on mechanical and geometrical characteristics of the gland and its internal structures.
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